Digital Outreach Intervention for Lung Cancer Screening

Not Applicable

Active, not recruiting

• Conditions: Lung Cancer
• Interventions: Other: mPATH-Lung; Other: Lung health video

• Registration Number: NCT04083859
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

mPATH-Lung (mobile Patient Technology for Health - Lung) is an innovative digital outreach program that identifies patients who qualify for lung cancer screening and helps them get screened. The study will: 1) Determine the effect of mPATH-Lung on receipt of lung cancer screening in a pragmatic randomized-controlled trial conducted with primary care patients in two large health networks, 2) Elucidate the drivers of patients' screening decisions and screening behavior; and 3) Explore implementation outcomes that will impact the sustainability and dissemination of mPATH-Lung using program data, surveys, and interviews.

This project will determine how mPATH-Lung affects patients' screening decisions and their completion of screening.

Detailed Description

Primary Objective: Determine the effectiveness of mPATH-Lung on receipt of LCS in a randomized pragmatic clinical trial of 1318 patients recruited from two large health networks, Wake Forest Baptist Health and the University of North Carolina at Chapel Hill.

Secondary Objectives:

* Elucidate the drivers of patients' decisions to receive or forgo LCS through a values clarification exercise embedded within mPATH-Lung and supplemental semi-structured interviews of at least 50 patients.

* Assess several critical implementation outcomes (reach, acceptability, and appropriateness) to inform the sustainability and scalability of mPATH-Lung across diverse primary care settings

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-08-30
• Study First Submitted QC: 2019-09-06
• Study First Posted: 2019-09-10
• Study Start: 2022-01-01
• Primary Completion: 2023-09-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-17
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 28410

Inclusion Criteria

• Meet the Medicare criteria for lung cancer screening, as updated in February 2022:

  • Age 50 - 77 years
  • Smoked at least 20 pack years
  • Current smoker or quit smoking within the past 15 years

• Be scheduled to see a primary care provider within the health network in the next 3-4 weeks

• Have a patient portal account or cellphone number listed in the electronic health record

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Exclusion Criteria

• Patients flagged as needing a language interpreter in the electronic health record (electronic messages and intervention is delivered in English only).

• Those for whom lung cancer screening would be inappropriate:

  • Prior history of lung cancer
  • Chest CT within the last 12 months
  • Those with medical conditions predicting shorter life expectancy
  • Patients whose home address is not within the state of North Carolina. (Due to telehealth guidelines)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mPATH-Lung	mPATH-Lung	Participants randomized to the mPATH arm will complete a self-survey and a brief video decision aid, and then invites them to estimate their personal risks and benefits of screening by completing 8 survey items needed to calculate their predicted risk of developing lung cancer based on the validated Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial Model 2012.
Usual care (CONTROL)	Lung health video	Participants randomized to the control arm will see an animated video about exercise for lung health based on recommendations from the European Lung Foundation. They will not be offered the opportunity to estimate their predicted benefits and harms of screening or to request a lung cancer screening visit.

Primary Outcome Measures

Name	Time	Method
Electronic health record-verified completion of a lung cancer screening CT scan	Within 16 weeks of enrollment	Completed any chest CT within 16 weeks of study randomization, as determined by electronic health record review

Secondary Outcome Measures

Name	Time	Method
Invasive procedures following LCS scan	1 year	The proportion of patients in each arm who undergo an invasive procedure following a LCS scan
Number of diagnosed lung cancers	16 months after randomization	Number of diagnosed lung cancers (detected by screening or other) within 16 months of randomization
How diagnosed lung cancers were detected	16 months after randomization	Proportion of patients who had lung cancers detected related to screening or incidentally.
Stage of lung cancers diagnosed	16 months after randomization	Stage of lung cancers diagnosed
Number of LCS false positives	1 year	A Lung-RADS 3 or 4 result with a negative completed work-up for lung cancer or no diagnosis of lung cancer within 12 months of the scan.
LCS Screening decision	Up to 16 weeks after day of enrollment	Patient intention to receive LCS as measured by a survey item in the mPATH-Lung group only
Proportion of patients with LCS clinic visits completed	16 weeks	The proportion of patients in each arm who have completed a LCS clinic visit
Proportion of patients with LCS scans ordered	16 weeks	The proportion of patients in each arm for whom a LCS scan was ordered
LCS clinic referral requested through mPATH	16 weeks	The proportion of patients in mPATH-Lung arm who completed a referral form with request for appointment.
Lung cancer screening test results	16 weeks	The results of a completed lung cancer screening CT, reported using the Lung-RADS classification
Proportion of patients with LCS clinic visits scheduled	16 weeks	The proportion of patients in each arm who have scheduled a LCS clinic visit, whether or not the visit is completed
Proportion of patients with complications following LCS	1 year	The proportion of patients in each arm who experience a complication from an invasive procedure following a LCS scan
Overscreening	1 year	The proportion of patients with screen diagnosed lung cancer who are deemed too ill for potentially curative surgery by blinded chart review.
Reach of digital outreach strategy	16 weeks	The proportion of patients sent a digital invitation who complete the eligibility questions on the study website.
Completion of mPATH-Lung program	16 weeks	The proportion of patients randomized to mPATH-Lung who complete the mPATH-Lung program to the point of indicating their screening decision.

Trial Locations

Locations (2)

University of North Carolina- Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States